NPC-12G Gel 0.2% Sirolimus PK Bridging Study

• Status: Completed
• Trial end date: 2019-06-17
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to describe the relative systemic bioavailability of topical and oral sirolimus formulations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nobelpharma
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria

• Male or female, non-smoker (no use within 3 months prior to screening), ≥ 18 and ≤ 65 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females

• Females of childbearing potential who are sexually active with a male partner must be willing to use one of acceptable contraceptive method throughout the study and for 12 weeks after the last study drug administration

Exclusion Criteria

• Any sign of eczema/dermatitis, skin lesion, wound, or infection at the application site, or any other conditions that would prevent a safe application of the gel formulation.

• Laser or surgery at the gel application site within 2 weeks before the gel application.

• Positive alcohol breath test, urine drug screen or urine cotinine test at screeningation

• History of allergic reactions or hypersensitivity to sirolimus, sirolimus derivatives, or excipient of NPC-12G Gel

• Use of any drugs known to induce or inhibit CYP3A4 metabolism within 30 days prior to the first study drug administration

• Positive pregnancy test at screening

• Breast-feeding subject

• History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening

• Positive QuantiFERON®-TB test with positive chest X-ray, indicating possible tuberculosis infection

• Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the study and up to 3 weeks after the last study drug administration